NCT02866968已完成不适用
Clinical Outcomes of Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of FLAPS
研究概览
简要总结
The study will be a pilot interventional case series aiming to treat 30 patients with Femtosecond Laser-assisted Pterygium Surgery (FLAPS). All patients included will undergo FLAPS in one eye. All procedures will be performed in SNEC by fully qualified surgeons. The doctor is informed of the procedure on the day of.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A pterygium will be defined as a wing-shaped growth of fibrotic connective tissue onto the cornea originating from the nasal conjunctiva.
- •Only patients older than 21 years will be included.
- •No gender criteria are applied.
- •Only individuals with the mental capacity to provide informed consent will be included.
- •More specifically, all the following inclusion criteria must be met:
- •Patients have primary pterygium encroaching onto the cornea by a minimum of 1 mm.
- •Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- •Patients are willing and able to return for scheduled follow-up examinations for 12 months after the surgery.
排除标准
- •Patients with prior history of pterygium surgery.
- •Patients with a prior history of glaucoma filtration surgery.
- •Patients with optic atrophy.
- •Patients with ocular pathology or disease that might confound the outcome or increase the risk of adverse events.
- •Patients with a prior history of vitrectomy.
- •Patients with central corneal scarring.
- •Patients with residual, recurrent, active or uncontrolled eyelid disease.
- •Patients with any conjunctival scarring other than pterygium, that could affect surgery outcome.
- •Patients with anterior segment pathology.
- •Patients with any corneal abnormality.
- •Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
- •Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
- •Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
研究组 & 干预措施
Femtosecond Laser-assisted Pterygium Surgery (FLAPS)
Experimental
All patients included will undergo FLAPS in one eye.
干预措施: FLAPS (Procedure)
结局指标
主要结局
Safety and Tolerability of FLAPS
时间窗: 12 month follow-up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Recurrence free survival over 12 months.(12 month follow-up)
- Visual acuity(Day 0, 7 and 1, 3, 6, 12 months)
- Refraction(Day 0, 7 and 1, 3, 6, 12 months)
- Corneal Topography((Day 0, 7 and 1, 3, 6, 12 months))
研究者
Jodhbir Mehta
Prof
Singapore Eye Research Institute
研究点 (1)
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